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Clinical Trials/NL-OMON32654
NL-OMON32654
Completed
Phase 2

Everolimus added to long acting octreotide as a volume reducing treatment of polycystic livers. - ELATE

niversitair Medisch Centrum Sint Radboud0 sites44 target enrollmentTBD
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Conditionspolycystic liver disease10019654

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
polycystic liver disease
Sponsor
niversitair Medisch Centrum Sint Radboud
Enrollment
44
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Sint Radboud

Eligibility Criteria

Inclusion Criteria

  • •18 \- 70 years of age
  • •Polycystic liver disease (PCLD), defined as \>\= 20 liver cysts and total liver volume must be at least 2500 mL.
  • •Informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements.

Exclusion Criteria

  • •\- Use of estrogens
  • •\- Pregnancy or breastfeeding at baseline/during study
  • •\- Severe cardiac or pulmonary disease
  • •\- Intervention \< 3 months before baseline
  • •\- Kidney transplantation
  • •\- Symptomatic gallstones
  • •\- Untreated hypercholesterolemie (fasting cholesterol \> 8 mmol/L)
  • •\- Granulocytopenia (white blood cell \< 3,000/mm3\) or thrombocytopenia (platelets \< 100,000/mm3\)
  • •\- Infection with hepatitis B, hepatitis C, HIV or TBC
  • •\- Mental illness that interferes with ability to comply with study protocol

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
Everolimus added to long acting octreotide as a volume reducing treatment of polycystic livers. - ELATEIsolated polycystic liver diseaseMedDRA version: 12.1Level: LLTClassification code 10048834Term: Polycystic liver diseaseMedDRA version: 12.1Level: PTClassification code 10048834Term: Polycystic liver disease
EUCTR2009-016640-39-NLRadboud University Nijmegen Medical Centre44
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